More Reasons Not to Sell Your Product in Europe

Blame the snake-oil salesmen. It's mostly their fault that we ended up with so much medical device regulation in the

Regulatory Depression? Blame Bad Design Controls (Video) The regulatory submission process can leave most anyone

Quality versus product development. It's a story as old as time - or at least as old as medical device

Bargaining with the FDA - or trying to - is the third stage of regulatory grief, but adopting that as your strategy will

Software is software is software, right? That's what Jose Bohorquez and I hear from medical device companies all

Y'all know that I am a big fan of appropriate regulation. 🤓 And having only properly validated medical devices and

Don't get mad at your regulatory consultant. We don't generate the regulatory standards, we just tell you what they

You've heard me tell you often enough that the first stage of regulatory grief is denial. And over the past two years,

Bargaining may work in politics or at the flea market but it won't help you gain FDA approval for your device. 😕

The second stage of regulatory grief is anger. 🤬 Anger aimed at the regulatory gods for getting in the way of your